ACTG Highlights

01 Clinical

Prophylaxis studies are the other major focus of ACTG PCP efforts. In this area,
the ACTG has:
* In less than 1 year, completed accrual for a 600-patient primary PCP prophylaxis
study of aerosolized pentamidine vs. dapsone vs. trimethoprinsulfamethoxazole.
* Nearly completed accrual for a secondary PCP prophylaxis study of aerosolized
pentamidine vs. trimethoprim/sulfamethoxazole.
Initial and salvage acute therapies for CMV are also being comprehensively
developed through the ACTG. In the area of acute, initial CMV therapies, the ACTG has:
* Established the ganciclovir Treatment IND for newly diagnosed CMV retinitis,
yielding evidence that supported the ganciclovir New Drug application.
* Developed an intermittent dosing schedule for intravenous foscarnet to treat
patients with CMV retinitis. Foscarnet was previously administered only by
continuous intravenous infusion.
* Completed 75 percent of accrual for a study of ganciclovir alone vs. ganciclovir
plus GMCSF, with GMCSF appearing to be useful in limiting the number of
episodes of neutropenia.
* Initiated a dose-ranging study of FIAC in certain people infected with CMV to
examine the drug's antiviral effect, pharmacokinetics, and toxicity.
Studies on salvage therapies for CMV performed by the ACTG include:
* Ongoing study of intravitreal ganciclovir for patients intolerant systemic
ganciclovir.
* Nearly complete accrual for a dose-comparison study of foscarnet maintenance,
including individuals who cannot be treated with ganciclovir.
The ACTG plans to evaluate prophylactic treatments for CMV infections in highrisk individuals as soon as a dose and schi dule of appropriate oral or long half-life
parenteral agent are identified.
Other important contributions to new and improved 01 therapies made by the ACTG
include:
* Demonstrated that fluconazole is better tolerated and at least as effective as
standard therapy, amphotericin B, for maintenance treatment of cryptococcal
meningitis.
* Contributed critical data to support the licensing of fluconazole for acute treatment
of cryptococcal meningitis.
* Demonstrated the feasibility of using itraconazole to suppress relapse of
disseminated histoplasmosis in people with AIDS.
Community Programs for Clinical Research on AIDS
The Community Programs for Clinical Research on AIDS (CPCRA), established in
October 1989 under the direction of Lawrence Deyton, M.D., was initiated by DAIDS to